Penna Gerson Oliveira, Bührer-Sékula Samira, Kerr Lígia Regina Sansigolo, Stefani Mariane Martins de Araújo, Rodrigues Laura Cunha, de Araújo Marcelo Grossi, Ramos Andrea Machado Coelho, de Andrade Ana Regina Coelho, Costa Maurício Barcelos, Rosa Patricia Sammarco, Gonçalves Heitor de Sá, Cruz Rossilene, Barreto Maurício Lima, Pontes Maria Araci de Andrade, Penna Maria Lúcia Fernandes
Tropical Medicine Centre, University of Brasília, Brasília, and Fiocruz Brasília, Brazil.
Tropical Pathology and Public Health Institute, Federal University of Goiás, Goiânia, Goiás, Brazil.
PLoS Negl Trop Dis. 2017 Jul 13;11(7):e0005725. doi: 10.1371/journal.pntd.0005725. eCollection 2017 Jul.
Leprosy control is based on early diagnosis and multidrug therapy. For treatment purposes, leprosy patients can be classified as paucibacillary (PB) or multibacillary (MB), according to the number of skin lesions. Studies regarding a uniform treatment regimen (U-MDT) for all leprosy patients have been encouraged by the WHO, rendering disease classification unnecessary.
An independent, randomized, controlled clinical trial conducted from 2007 to 2015 in Brazil, compared main outcomes (frequency of reactions, bacilloscopic index trend, disability progression and relapse rates) among MB patients treated with a uniform regimen/U-MDT (dapsone+rifampicin+clofazimine for six months) versus WHO regular-MDT/R-MDT (dapsone+rifampicin+clofazimine for 12 months). A total of 613 newly diagnosed, untreated MB patients with high bacterial load were included. There was no statistically significant difference in Kaplan-Meyer survival function regarding reaction or disability progression among patients in the U-MDT and R-MDT groups, with more than 25% disability progression in both groups. The full mixed effects model adjusted for the bacilloscopic index average trend in time showed no statistically significant difference for the regression coefficient in both groups and for interaction variables that included treatment group. During active follow up, four patients in U-MDT group relapsed representing a relapse rate of 2.6 per 1000 patients per year of active follow up (95% CI [0·81, 6·2] per 1000). During passive follow up three patients relapsed in U-MDT and one in R-MTD. As this period corresponds to passive follow up, sensitivity analysis estimated the relapse rate for the entire follow up period between 2·9- and 4·5 per 1000 people per year.
Our results on the first randomized and controlled study on U-MDT together with the results from three previous studies performed in China, India and Bangladesh, support the hypothesis that UMDT is an acceptable option to be adopted in endemic countries to treat leprosy patients in the field worldwide.
ClinicalTrials.gov: NCT00669643.
麻风病控制基于早期诊断和联合化疗。出于治疗目的，麻风病患者可根据皮肤损害数量分为少菌型（PB）或多菌型（MB）。世界卫生组织鼓励开展针对所有麻风病患者的统一治疗方案（U-MDT）研究，使得疾病分类不再必要。
2007年至2015年在巴西进行了一项独立、随机、对照临床试验，比较了采用统一方案/U-MDT（氨苯砜+利福平+氯法齐明治疗六个月）治疗的多菌型患者与世界卫生组织常规MDT/R-MDT（氨苯砜+利福平+氯法齐明治疗12个月）的主要结局（反应频率、细菌学指数趋势、残疾进展和复发率）。共纳入613例新诊断、未治疗且细菌载量高的多菌型患者。U-MDT组和R-MDT组患者在反应或残疾进展方面的Kaplan-Meier生存函数无统计学显著差异，两组残疾进展率均超过25%。根据细菌学指数随时间的平均趋势进行调整的完全混合效应模型显示，两组的回归系数以及包括治疗组的交互变量均无统计学显著差异。在主动随访期间，U-MDT组有4例患者复发，每年每1000例主动随访患者的复发率为2.6（95%CI[0·81, 6·2]/1000）。在被动随访期间，U-MDT组有3例患者复发，R-MTD组有1例患者复发。由于此期间对应被动随访，敏感性分析估计整个随访期间每年每1000人的复发率在2·9至4·5之间。
我们关于U-MDT的首次随机对照研究结果以及之前在中国、印度和孟加拉国进行的三项研究结果支持以下假设：在流行国家，UMDT是在全球范围内治疗麻风病患者的一种可接受的选择。
ClinicalTrials.gov：NCT00669643。
